Recent Brazil Regulatory Updates

There have been a large number of regulatory developments in Brazil. Two resolutions have been published in quick succession related to medical devices and IVDs, RDC 751/2022 and RDC 830/2023, respectively.

About the presenter

Luiz Levy, RAC, manager, Quality and Regulatory Affairs Brazil 

Luiz Levy is located in São Paulo, Brazil, and has over ten years of medical device industry experience, primarily focused on high-risk devices, including implantable devices, electrical medical equipment and disposables subject to INMETRO Certification. Levy’s background includes: implementing and auditing quality systems to B-GMP Regulation RDC 665/2022, ISO 13485:2016, Directive 93/42/EEC, EU Regulation 2017/745 (MDR), FDA 21 CFR 807, FDA QSR 21 CFR 820, MDSAP-Medical device single audit program; performing multiple local and foreign (U.S., Europe, Japan) audits to prepare companies for ANVISA inspections; assisting companies during ANVISA inspections; compiling medical device and IVD applications; clinical data review; and compiling and peer reviewing market access reports.

As manager of Quality and Regulatory Affairs, Levy has peer-reviewed more than 300 regulatory filings and reports, conducted multiple on-site audits on local and foreign manufacturers, performed internal audits, and performed or reviewed more than 400 classifications/technical files of healthcare products. He also contributed to the final draft of new ANVISA (RDC) regulations during a series of strategic meetings with the Agency. Levy is the designated health manager for Emergo’s Brazil Registration Holder services, and he additionally manages Emergo Brazil’s RDC 665/2022 quality system. Prior to Emergo, he held RA/QA positions at CPL Medicals, Goen3 and Medics.